Information blocking means actions by healthcare groups that stop or limit access to or sharing of electronic health information (EHI), except when the law or rules allow it. The 21st Century Cures Act, passed in 2016, aimed to reduce problems in sharing electronic health records (EHR) and make data sharing normal in healthcare.
The rules apply to healthcare providers, certified health IT developers, and health information networks or exchanges (HINs/HIEs). These groups have different rules depending on what they know about blocking information. For example, IT developers are judged on knowing how design choices affect access, while providers are judged on whether their actions are unreasonable or meant to stop patients or others from getting needed information.
The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) looks into claims about information blocking. Penalties can be large. For instance, technology developers can be fined up to $1 million for each violation. Healthcare providers may face other regulatory consequences.
Even though the rules are strict, there are exceptions called “information blocking exceptions” under 45 CFR Part 171. These exceptions protect actors who meet certain conditions but do not stop all claims of information blocking. Examples include protecting patient privacy, avoiding harm to patients, keeping data secure, or when technical issues make sharing data impossible.
One exception, called the “Manner Exception,” means healthcare actors must provide electronic health information how the requester asks if it is reasonable and uses certified technology standards. This lets providers and vendors respond flexibly while following the rules.
Interoperability means health IT systems and software can work together, share data, and use that data effectively. It allows patient information made or saved in one place to be accessed by another provider without extra work or delays.
As of 2023, about 70% of non-federal acute care hospitals in the U.S. sometimes or regularly handle the four main parts of interoperability: sending, receiving, finding, and using patient health data. This is up 52% since 2018, but 30% of hospitals still are not fully interoperable.
Interoperability is important for good care coordination. Hospitals active in interoperability report that 92% of patient info from outside providers is available electronically during care. About 70% of doctors in these hospitals use that info regularly. Hospitals with less interoperability have lower data access and use.
Differences in interoperability often depend on hospital size, affiliation, and location. Bigger, city, and system-connected hospitals do better, with 53% fully interoperable. Only 22% of independent hospitals do this. Smaller, rural, and critical access hospitals often find full interoperability harder, which affects patient care especially in underserved areas.
Even though more clinical info is available at care points, many doctors do not regularly use it, often because of workflow problems and poor integration with health IT systems.
Healthcare providers and managers are using artificial intelligence (AI) and automated processes more to follow information blocking rules and improve interoperability. These tools help make patient data easier to access, cut down on paperwork, and improve care quality.
For medical practice leaders in the U.S., knowing information blocking rules and interoperability requirements is key to running efficiently and following the law. Important points include:
Following information blocking rules and supporting interoperable health data sharing helps healthcare groups stay lawful and improve patient care. With more federal attention on easy, safe, and efficient data flow, medical practices that use current technology and good governance will handle risks better and run more smoothly.
Telehealth programs must comply with various regulations, including licensing, informed consent, and reimbursement rules. Compliance ensures that the delivery of telehealth services aligns with legal requirements and healthcare standards.
Challenges include meeting state-specific licensure requirements, navigating scope of practice limitations, and addressing reimbursement policies, particularly regarding insurance coverage for telehealth services.
The Anti-Kickback Statute prohibits compensation arrangements that could influence medical decision-making. Providers must structure telehealth partnerships carefully to avoid potential violations.
Remote patient monitoring must adhere to guidelines concerning patient consent, data security, and accurate billing to ensure compliance with HIPAA and reimbursement regulations.
Informed consent requires that patients are fully aware of the telehealth process, including any risks and limitations, ensuring they understand how their data will be used and shared.
Stark Law prohibits self-referrals for certain healthcare services. Telehealth providers must navigate these restrictions when forming partnerships to avoid significant penalties.
Information blocking regulations require healthcare providers to share patient information more freely. Compliance prepares providers for increased interoperability and avoids penalties.
Organizations should ensure telehealth partnerships comply with state regulations, financial arrangements, and enforce data security protocols to mitigate legal risks.
HIPAA ensures that patient information is protected during telehealth consultations. Providers must implement safeguards for data security and patient privacy.
Reimbursement for telehealth varies by payer and geographical region. Providers must track billing codes and comply with Medicare and Medicaid guidelines to secure payment.
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